Actively Recruiting
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome
Led by Kind Pharmaceuticals LLC · Updated on 2026-02-27
63
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, multicenter, randomized, open-lable, dose ranging study to evaluate the efficacy and safety of AND017 for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS) in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).
CONDITIONS
Official Title
A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary myelodysplastic syndrome with a very low, low, or intermediate risk PISS-R grading at least 12 weeks before first dose
- Non-5q(del)-associated myelodysplastic syndrome
- Two non-transfused hemoglobin measurements between 6.0 and 10.0 g/dL during screening, at least one week apart, with no more than 1.3 g/dL difference
- Non-transfused or low transfusion burden defined as specified red blood cell transfusion limits in the 16 weeks before randomization
- Baseline erythropoietin (EPO) level less than or equal to 500 mU/mL
- Platelet count of at least 30,000/mm3 and absolute neutrophil count of at least 800/mm3
- Adequate liver function with total bilirubin less than 2 times upper limit of normal (or less than 3 times for Gilbert's syndrome), AST less than 3 times ULN, and ALT less than 3 times ULN
You will not qualify if you...
- Diagnosis of secondary myelodysplastic syndrome or anemia from other causes
- Significant myelofibrosis with fibrosis grade 2 or higher
- Planned chemotherapy or whole brain/spinal cord radiotherapy during study
- Previous diagnosis of high or very high risk MDS IPSS-R
- Prior or planned hematopoietic stem cell transplant during study
- Recent treatment with G-CSF, thrombopoietin or receptor agonists within 8 weeks before first dose
- Treatment with specific drugs (antithymocyte globulin, azacitidine, decitabine, cyclosporine, thalidomide, lenalidomide) within 12 weeks before first dose
- Active infection or inflammatory disease requiring systemic therapy
- Retinal neovascularization requiring treatment
- Inability to take oral medications or gastrointestinal conditions affecting absorption
- Significant bleeding within 4 weeks before first dose or uncorrected bleeding risk
- Uncontrolled hypertension
- Comorbid heart failure of NYHA class III or higher
- Significant or active liver disease at screening
- Prior treatment with hypoxia-inducing factor-prolyl hydroxylase inhibitor within 8 weeks
- Prior treatment with erythropoietic ESA within 8 weeks
- Prior treatment with androgenic anabolic steroids or similar agents within 8 weeks
- Prior treatment with iron chelators within 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 30003
Actively Recruiting
Research Team
Y
Yusha Zhu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here